Imaging collagen in early interstitial lung disease
Collagen-targeted PET Imaging for Early Interstitial Lung Disease
This study is testing a special imaging tool to see if it can spot early signs of collagen buildup in people with early interstitial lung disease, including those related to patients with pulmonary fibrosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05417776 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the PET imaging probe [68Ga]CBP8 in detecting collagen deposition in patients with early interstitial lung disease. The probe selectively binds to collagen type I, which is crucial in the development of pulmonary fibrosis. The study aims to determine if [68Ga]CBP8-PET imaging can identify increased collagen levels and if the uptake of the probe can predict disease progression. Participants include first-degree relatives of pulmonary fibrosis patients and individuals with interstitial lung abnormalities.
Who should consider this trial
Good fit: Ideal candidates are individuals over 40 years old, either first-degree relatives of pulmonary fibrosis patients or those with interstitial lung abnormalities.
Not a fit: Patients with a known history of interstitial lung disease or those with certain electrical or ferromagnetic implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of interstitial lung disease.
How similar studies have performed: Other studies have shown promise in using imaging techniques for detecting lung fibrosis, but this specific approach with [68Ga]CBP8 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Group 1: First degree relatives of a family member with pulmonary fibrosis (n=8) * Age greater than 40 years * Have the ability to give written informed consent * First degree relative of a family member with pulmonary fibrosis * No known history of interstitial lung disease * No tobacco use within the prior 6 months. Group 2: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) (n=22) * Age greater than 40 years * Have the ability to give written informed consent * ILAs or early ILD (defined by presence of reticular markings and / or traction bronchiectasis but absence of a definite UIP pattern) * No tobacco use within the prior 6 months. Exclusion criteria: * Electrical implants such as cardiac pacemaker or perfusion pump * Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing * Historical eGFR of less than 30 mL/min/1.73 m2 * Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate) * Claustrophobic reactions * Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months) * Unable to lie comfortably on a bed inside the MR-PET * BMI \> 33 (limit of the PET-MRI table) * Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures) * Pneumonia or other acute respiratory illness within 6 weeks of study entry * Parenchymal lung disease except for ILD/ILAs or emphysema * Acute exacerbation of ILD within the prior 6 months * VATS within the prior 6 months * Prior radiation therapy to the thorax * Known allergy to gadolinium.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Sydney B Montesi, MD
- Email: sbmontesi@partners.org
- Phone: 617-724-4030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.